UPDATE ON VALIDATION STATUS AND INDUSTRY UTILIZATION OF NORMAL HUMAN 3D (NHU-3D) ANIMAL ALTERNATIVE MODELS.
Progress in in vitro tissue engineering over the last several decades has contributed to a significant decrease in animal use for industrial risk and safety assessment of products and ingredients. MatTek Corporation has a long-standing involvement in development, production and validation of animal alternative in vitro models produced from normal human cells (NHu-3D models). The currently available suite of NHu-3D models includes: Skin (EpiDerm, MelanoDerm, EpiDerm-FT), Ocular (EpiOcular, EpiOcular-FT), Airway (EpiAirway, EpiAirway-FT), Vaginal (EpiVaginal, EpiVaginal-FT), Oral (EpiOral, EpiGingival, EpiGingival-FT) and dendritic cells (DC-100). EpiDerm NHu-3D skin models are widely utilized in preclinical toxicology and efficacy applications during industrial product development (e.g. skin penetration, skin lightening, irritation, corrosion, ingredient efficacy and wound healing). In addition, the EpiDerm model is formally validated by ECVAM and accepted by OECD for regulatory use in skin corrosion (OECD TG 431, 2004), and irritation (OECD TG 439, 2009) and is pre-validated for phototoxicity testing. The EpiOcular model is widely utilized for ocular irritation studies during industrial product development. The EpiOcular ET-50 assay is currently an EPA accepted method for testing of antimicrobial cleaning products. In addition, an EpiOcular eye irritation test (EIT) is currently undergoing formal COLIPA-ECVAM validation for regulatory use. Additional NHu-3D models and assays for toxicity, allergenicity, genotoxicity, and other animal alternative applications are under development. Thus, NHu-3D models have made significant contributions to reduction of animal use in industrial product development and regulatory testing. MatTek will continue to devote focused efforts toward further elimination of animal use in biological science and regulatory testing.
Antimicrobial cleaning products, DC-100, EpiAirway, EpiAirwayFT, EpiDerm, EpidermFT, EpiGingival, EpiGingivalFT, EpiOcular, EpiOcularFT, EpiOral, EpiVaginal, EpiVaginalFT, Eye irritation, Genotoxicity, Good Manufacturing Practices (GMP), Inhalation toxicity, MelanoDerm, Mucosa irritation, NHu-3D models, Phototoxicity, Skin corrosion, Skin irritation, Skin irritation of cosmetic formulations, Skin penetration, Validation
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